• Job Description

  Req#: R535814
  Work Flexibility: Hybrid or Onsite

  Stryker is hiring a Specialist, Post Market Quality in Portage, MI supporting Instruments! In this role, you will support to the Post-Market Quality team that is responsible for both domestic and international complaint handling along with the product field action team. Specifically, this position is responsible for the coordination of material and information to meet quality and regulatory requirements.

  Work Flexibility: Hybrid. This role requires reasonable proximity to our Stryker facility in Portage, MI. You should be comfortable working 3-days onsite.

  What you will do

  • Participation in product field action strategy meetings.

  • Creation and mailing of customer letters for product field action notification.

  • Communicate directly with customers to perform product field action effectiveness checks on open actions.

  • Coordination with customer care teams on replacement products and credits.

  • Communicate with internal and external resources globally on product field action execution activities.

  • Provide updates within Trackwise on status of product field action executions.

  • Monitor and facilitate product return for complaint investigation and analysis, including communicating directly with customers and sales teams.

  • Provide updates within Trackwise on status of event detail information and product returns to support complaint handling activities.

  • Work with internal and external partners on the facilitation of movement of complaint return product.

  • May support international and domestic complaint entry.

  • Support management with various weekly, monthly and quarterly reporting as needed.

  • Work with internal supporting teams on quality of data coming into post market.

  • May monitor, create and assign regulatory communications to quality specialists for resolution.

  • Involvement in team projects as requested.

  What you need

  Required:

  • Bachelor’s Degree or higher with no prior work experience necessary.

  Preferred:

  • Bachelors degree or higher in Regulatory Science, Engineering, Science related discipline.

  • Regulatory Affairs Certification (RAC) preferred.

  • Proven experience in regulated industries, with a strong preference for the medical device sector.

  • Expertise in post-market quality processes, including complaint handling and product field action process as required by regulatory agencies.

  Travel Percentage: 10%

  Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

  Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

• About the company

  Stryker Corporation is an American multinational medical technologies firm based in Kalamazoo, Michigan.

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